In a groundbreaking 24-week double-blind randomised controlled trial, a novel triple combination cream has shown promising efficacy and safety in treating melasma, potentially offering a superior alternative to the established Kligman's Trio.
STUDY OVERVIEW
The study titled "Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomised controlled trial" was conducted to evaluate a new treatment for melasma. This trial was carried out over 24 weeks in Nice, France, involving 40 patients diagnosed with melasma. The study design was double-blind, prospective, and randomised, ensuring robust and unbiased results. Participants were divided into two groups: one receiving the novel triple combination cream (NT) and the other receiving Kligman's Trio (KT). Baseline characteristics included patients with moderate to severe melasma, and inclusion criteria ensured participants had not used any other melasma treatments prior to the study.
Treatment Details
The NT cream comprised isobutylamido-thiazolyl-resorcinol, retinoic acid, and corticosteroid, while KT consisted of hydroquinone, retinoic acid, and corticosteroid. Both treatments were applied once daily for the first 12 weeks, accompanied by a standardised sunscreen regimen. This application regimen was designed to maximize efficacy while minimizing potential side effects. No adjunctive treatments were used during the trial, ensuring that the results were solely attributable to the creams being tested.
Efficacy Outcomes
The primary endpoints of the study included improvement in melasma severity, reduction in pigmentation, and overall skin tone. These were measured using the modified Melasma Area Severity Index (mMASI) after 12 weeks. Results indicated significant improvements in mMASI scores for both groups. The NT group achieved a 63% reduction (mean score of 2.93), while the KT group saw a 39% reduction (mean score of 3.51). Although the NT group showed a greater reduction, the difference was not statistically significant (p = 0.14). Quality of life was assessed using the MelasQoL score, with the NT group reporting a more substantial improvement compared to the KT group, showing a significant difference (p = 0.0006).
SAFETY AND TOLERABILITY
Safety profiles were a crucial aspect of the study. Both treatments were generally well-tolerated, with mild and transient adverse events such as erythema and irritation reported in both groups. Notably, only one patient in the KT group discontinued treatment due to an adverse event. Both groups experienced some relapse of melasma during the follow-up period, but no rebound effect was observed after treatment cessation. The absence of hydroquinone in the NT cream potentially contributed to its favourable safety profile.
IMPLICATIONS FOR CLINICAL PRACTICE
The study's findings are highly relevant for pharmacists recommending treatments for melasma. The NT cream demonstrated promising results, offering an effective and well-tolerated alternative to Kligman's Trio. This novel treatment could be particularly beneficial for patients seeking options with a better safety profile, especially those concerned about the adverse effects associated with hydroquinone. Pharmacists can consider the NT cream as a viable option for managing melasma, providing patients with an effective treatment that also prioritises safety.
Source: Bertold, et al. (2023). Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4. PMID: 37620285. Available from: https://onlinelibrary.wiley.com/doi/10.1111/jdv.19455.
